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# 5 Observations on Excelvision FDA-483
- URL: https://www.fdaweb.com/5-observations-on-excelvision-fda-483/
- Published: 2026-04-28T12:00:00.000Z
- Updated: 2026-09-14T13:38:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161057

FDA has released the form FDA-483 issued following an 11/12-11/19/2024 inspection at Excelvision, a drug manufacturer in Annonay, Ardèche, France. The five inspection observations were:

- failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up;
- failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic process;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions; and
- failure of laboratory records to include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.